Common use of INSPECTIONS AND CONTROLS Clause in Contracts

INSPECTIONS AND CONTROLS. 3.1 Subject to confidentiality obligations contained in Section 7, Sumika agrees to allow inspections of its manufacturing facilities in which the Compound is being manufactured, analyzed or tested, by representatives of BioNumerik or Grelan Pharmaceutical Co., Ltd. ("Grelan"), as well as FDA and other material regulatory authorities of the U.S. or other governments, during normal working hours upon prior written notice to Sumika. Sumika shall grant access to such premises and to the documentation necessary for or appropriate to the manufacturing and quality control of the Compound. BioNumerik shall cause Grelan to comply with the Confidentiality obligations set forth in this Agreement and shall be responsible for any breach of such obligations by Grelan. 3.2 Sumika shall ensure all manufacturing, test and inspection equipment is maintained under a documented calibration program that is ISO9002 and ICH compliant. This includes providing equipment calibration certifications as required. 3.3 Sumika will maintain environmental controls, including particulate and bioburden monitoring, pest controls and housekeeping procedures in accordance with FDA cGMP, ISO9002 and ICH regulations and guidelines. The use of supplies of process water, air and particulate handling, etc., for cGMP manufacture of the Compound, shall be consistent with FDA cGMP specifications and ICH regulations and guidelines. 3.4 Sumika shall maintain a Quality Control department, which is a distinct department separate from manufacturing. Sumika Quality Control/Quality Assurance will perform incoming, in-process and finished product inspections, review records, perform line clearances, maintain batch history records, provide batch history records for review and accuracy and completeness and provide product release services in accordance with cGMP and ICH regulations and guidelines. 3.5 Sumika will promptly notify BioNumerik of any FDA or other material regulatory inspection of Sumika related to the Compound, and will promptly provide BioNumerik with a copy of documentation and Sumika's correspondence and plans to address any deficiencies relating to such inspection.

INSPECTIONS AND CONTROLS. 3.1 Subject to confidentiality obligations contained in Section 7, Sumika agrees RPS agrees, without additional charge to BioNumerik, to allow inspections of its manufacturing facilities in which the Compound is being manufactured, analyzed or tested, by representatives of BioNumerik or Grelan Pharmaceutical Co., Ltd. its agents ("Grelan"), as well as FDA and other material including inspections by regulatory authorities of the U.S. or other governments, authorities) during normal working hours upon prior written notice to SumikaRPS, which notice will occur at least three days in advance of the inspection, unless not possible with respect to an inspection by a regulatory agency. Sumika RPS shall grant access to such premises and to the documentation necessary for or appropriate to the manufacturing and quality control of the Compound. BioNumerik During such visits, RPS shall cause Grelan make sure that at least one technical person from each of Quality Assurance, Quality Control, project teams, and, if reasonably possible, business development/coordination is present to comply answer questions or discuss matters of concern with the Confidentiality obligations set forth in this Agreement and shall be responsible for any breach of BioNumerik personnel conducting such obligations by Grelanaudit or inspection. 3.2 Sumika RPS shall ensure all relevant and/or critical manufacturing, test and inspection equipment is maintained under a documented calibration program that is ISO9002 and ICH compliantmaintenance program. This includes providing equipment calibration certifications as required. 3.3 Sumika RPS will maintain environmental controls, including particulate and bioburden monitoring, pest controls and housekeeping procedures in accordance with FDA cGMP, ISO9002 cGMP and ICH regulations and guidelines. The use of supplies of process water, air and particulate handling, etc., for cGMP manufacture of the Compound, shall be consistent with relevant FDA cGMP specifications and ICH regulations and guidelines. 3.4 Sumika RPS shall maintain a Quality Control quality control department, which is a distinct department separate from manufacturing. Sumika Quality ControlRPS quality control/Quality Assurance quality assurance will perform incoming, in-process and finished product inspections, review records, perform line clearancesclearance inspections, maintain batch history records, provide batch history records for review and accuracy and completeness and provide product release services services. RPS [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. will promptly inform BioNumerik of any changes in accordance with cGMP and ICH regulations and guidelinesmanagement control related to the work conducted hereunder. 3.5 Sumika The conditions to be maintained for the storage of API, raw materials, and intermediates are set forth on Annex 7. 3.6 RPS will promptly notify BioNumerik of any FDA or other material regulatory inspection of Sumika RPS related to the Compound, and will promptly provide BioNumerik with a copy of documentation and Sumika's correspondence and plans to address any deficiencies relating to such inspection. BioNumerik shall have the right to communicate at any time with the FDA or any regulatory agency or body regarding such matters, provided any communication with the FDA regarding potential inspection of RPS' plants should be done in coordination with RPS. BioNumerik will provide appropriate support for any such inspection, including data and information relating to critical parameters and justification for the process for manufacturing the Compound. 3.7 At all times during the term of this Agreement, each of the parties shall carry and keep in force a general liability insurance policy, in support of their liability obligations to one another hereunder.[**] Certificate of Insurance evidencing RPS's coverage and a Certificate of Insurance evidencing BioNumerik's coverage are attached hereto as Annex 8 hereto. .